Cleared Traditional

DEVILBISS SMARTLINK II SYSTEM

K140880 · Devilbiss Healthcare, LLC · Anesthesiology
Aug 2014
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K140880 is an FDA 510(k) clearance for the DEVILBISS SMARTLINK II SYSTEM, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Devilbiss Healthcare, LLC (Somerset, US). The FDA issued a Cleared decision on August 4, 2014, 119 days after receiving the submission on April 7, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K140880 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2014
Decision Date August 04, 2014
Days to Decision 119 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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